某肿瘤专科医院临床试验药房管理实践与经验分享  

Practice and experience in the management of clinical trial pharmacy at an oncology hospital

作　　者：王肇聪 杨洋[2] 张峰 许芳 李天恩 魏学燕 胡喆 陈健[1] WANG Zhao-cong;YANG Yang;ZHANG Feng;XU Fang;LI Tian-en;WEI Xue-yan;HU Zhe;CHEN Jian(Drug Clinical Trial Institution,Hubei Cancer Hospital/Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430079,China;Office of the Leading Group on Infrastructure Work,Hubei Cancer Hospital/Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430079,China)

机构地区：[1]华中科技大学同济医学院附属肿瘤医院/湖北省肿瘤医院药物临床试验机构,武汉430079 [2]华中科技大学同济医学院附属肿瘤医院/湖北省肿瘤医院基建工作领导小组办公室,武汉430079

出　　处：《中国新药杂志》2025年第7期741-746,共6页Chinese Journal of New Drugs

基　　金：武汉市知识创新专项基础研究项目(2022020801010511)。

摘　　要：抗肿瘤药物已成为我国新药研发的热门板块,各医疗机构承接抗肿瘤药物临床试验项目数量也与日俱增。本文从肿瘤医院视角,按照临床试验用药品管理流程,即药品的接收、储存、发放和回收环节,结合我院抗肿瘤药物临床试验药品管理实例,分析并探讨各工作环节中的风险因素,总结抗肿瘤药物临床试验药品管理的特殊性,提出临床试验用药品管理工作建议,以期提高药品管理工作质量及效率,为临床试验专用药房的建立以及规范的临床试验用药品管理提供借鉴。The development of anti-cancer drugs has become a prominent focus in the field of new drug research and development in China.The number of clinical trial projects for anti-cancer drugs undertaken by various medical institutions is also increasing.From the perspective of an oncology hospital,this paper analyzes and discusses the risk factors in each stage of working,summarizes the particularity of clinical trial drug management of anti-cancer drugs,based on our experience and drug management process,namely receipt,storage,dispensation and return of investigational products.The authors also put forward suggestions on clinical trial drug management to improve the quality and efficiency of drug management,which might provide references for the construction of clinical trial pharmacy and standardized drug management for clinical trials.

关 键 词：抗肿瘤药物 临床试验 药品管理 药房建设 

分 类 号：R95[医药卫生—药学]